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Pharmacologic class: Monoclonal antibody
Therapeutic class: Immunologic agent
Pregnancy risk category C
Neutralizes and suppresses activity of syncytial virus in respiratory tract, inhibiting respiratory syncytial virus (RSV) replication
Injection: 50 mg, 100-mg vial
⊘Indications and dosages
➣ To prevent serious lower respiratory disease caused by RSV in high-risk children
Children: 15 mg/kg I.M. q month throughout RSV season
• Hypersensitivity to drug or its components
Use cautiously in:
• thrombocytopenia, coagulation disorders, established RSV infection.
☞ Keep epinephrine 1:1,000 available in case anaphylaxis occurs. (However, drug isn't known to cause anaphylaxis.)
• Dilute in sterile water for injection. Gently swirl for 30 seconds to avoid foaming.
• Keep reconstituted solution at room temperature for at least 20 minutes before administering. Give within 6 hours of reconstitution.
• Inject I.M. into anterolateral thigh. Avoid gluteal injection, which may damage sciatic nerve.
CNS: nervousness, pain
EENT: conjunctivitis, otitis media, rhinitis, pharyngitis, sinusitis
GI: vomiting, diarrhea, gastroenteritis, oral moniliasis
Respiratory: upper respiratory tract infection, cough, wheezing, dyspnea, bronchiolitis, bronchitis, pneumonia, croup, asthma, apnea
Skin: rash, fungal dermatitis, eczema
Other: hernia, pain, fever, injection site reaction, viral infection, flulike symptoms, failure to thrive
Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase: increased levels
Hemoglobin: decreased level Immunological-based RSV diagnostic tests: interference, possibly leading to false-negative test results
☞ Watch closely for signs and symptoms of anaphylaxis immediately after dosing.
• Assess for signs and symptoms of infection, particularly EENT and respiratory infection.
• Monitor liver function tests and CBC.
• Assess patient's weight and hydration status.
• Tell parent that monthly injections are necessary during RSV season (November through April).
• Inform parent that drug may cause GI symptoms and failure to thrive. Provide dietary consultation as needed.
☞ Caution parent that EENT and respiratory infections may follow administration. Advise parent to contact pre-scriber immediately if child has fever or other signs or symptoms of infection.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.